Onyx Pharmaceuticals, Inc.16 reviews–South San Francisco, CA
Onyx Pharmaceuticals, Inc.
- 30+ days ago
Leads and works collaboratively with multiple functions including but not limited to Biostatistics, Statistical Programming, Clinical Data Management, Clinical Science, Drug Safety, Medical Writing, Regulatory, Project Management, Research, and IT to develop internal standards, tools/systems, and processes for data collection, statistical data analysis and reporting.
Identifies, develops, and implements new standards, tools/systems, and/or new processes to increase Biometrics productivity and efficiencies.
Serves as governance board liaison and/or leads/provides oversight for standards, tools/systems, and process improvements across the Biometric functions.
Assists to ensure adequate development and implementation of SOPs and Working Instructions within Biometrics and adequate integration of Biometrics functions (CDM, Statistical Programming, and Biostatistics).
Evaluates ongoing processes and identifies gaps for process improvements.
Coordinates and provides solutions for special requests from other functions.
Coordinates and harmonizes strategic initiatives across Biometrics functions and between Biometrics and other functions.
Plans, negotiates/recruits, and manages external partnerships, alliances, collaborators, contractors, CROs, and FSPs
Requirements: Work Experience:
A minimum of 12 years of experience in biotech/pharmaceutical industry with a BA/BS degree
At least 6 years of management experience
8+ years of regulatory experience
Experience in supporting Oncology preferred
Experience and in-depth knowledge in CDISC including CDASH, SDTM, ADaM, Metadata, and controlled terminologies
Successful e-Submission experience based on CDISC requirements.
Experience in working in and contributing to cross-functional teams
Proven track record in forming and managing a cross-functional team to support multiple projects.
Knowledgeable in SAS, clinical development processes, regulatory and ICH guidelines.
Oncology experience preferred.
BA/BS, MA/MS, or PhD in Biostatistics/Computer Science or equivalent (MA/MS or PhD preferred).
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